Immobilisation of torus fractures of the wrist in children (FORCE): a randomised controlled equivalence trial in the UK
Authors: Daniel C Perry, Juul Achten, Ruth Knight, Duncan Appelbe, Susan J Dutton, Melina Dritsaki, James M Mason, Damian T Roland, Shrouk Messahel, James Widnall, Matthew L Costa, Rahail Ahmad, Anastasia Alcock, Andrew Appelboam, Lisa Armour, Jane Bayreuther, Rhys Beynon, Charlotte Brown, Emily Cadman, Nadine Darlow, Tessa Davis, Phoebe Gibson, Colin Gilhooley, Sylvester Gomes, Christopher Gough, David Hartin, Stuart Hartshorn, Temem (Tim) Hussan, Neha Jain, Emma Jenkinson, Graham Johnson, Lisa Kehler, Matthew Long, Mark Lyttle, Shahab Manouchehri, Christopher McKie, David Metcalfe, Louise Morgans, Niall Mullen, Alex Novak, Catherine Nunn, Kath O'Hagan, Aman Paul, Jennifer Preston, Shammi Ramlakhan, Aarani Somaskanthan, Yok Weng Tan, Manish Thakker, Krishna Vemulapalli, Joanna Weekes, Daniel Westacott, Sarah Wilson, Darryl Wood, Louise Conner, Nicolas Nicolaou, Fergal Monsell
Journal: The Lancet (2022)

BackgroundThe most common fractures in children are torus (buckle) fractures of the wrist. Controversy exists over treatment, which ranges from splint immobilisation and discharge to cast immobilisation, follow-up, and repeat imaging. This study compared pain and function in affected children offered a soft bandage and immediate discharge with those receiving rigid immobilisation and follow-up as per treating centre protocol.MethodsIn this randomised controlled equivalence trial we included 965 children (aged 4–15 years) with a distal radius torus fracture from 23 hospitals in the UK. Children were randomly allocated in a 1:1 ratio to the offer of bandage group or rigid immobilisation group using bespoke web-based randomisation software. Treating clinicians, participants, and their families could not be masked to treatment allocation. Exclusion criteria included multiple injuries, diagnosis at more than 36 h after injury, and inability to complete follow-up. The primary outcome was pain at 3-days post-randomisation measured using Wong-Baker FACES Pain Rating Scale. We performed a modified intention-to-treat and per protocol analysis. The trial was registered with ISRCTN registry, ISRCTN13955395.FindingsBetween Jan 16, 2019, and July 13, 2020, 965 children were randomly allocated to a group, 489 to the offer of a bandage group and 476 to the rigid immobilisation group, 379 (39%) were girls and 586 (61%) were boys. Primary outcome data was collected for 908 (94%) of participants, all of whom were included in the modified intention-to-treat analysis. Pain was equivalent at 3 days with 3·21 points (SD 2·08) in the offer of bandage group versus 3·14 points (2·11) in the rigid immobilisation group. With reference to a prespecified equivalence margin of 1·0, the adjusted difference in the intention-to-treat population was –0·10 (95% CI –0·37 to 0·17) and–0·06 (95% CI –0·34 to 0·21) in the per-protocol population.InterpretationThis trial found equivalence in pain at 3 days in children with a torus fracture of the distal radius assigned to the offer of a bandage group or the rigid immobilisation group, with no between-group differences in pain or function during the 6 weeks of follow-up.FundingUK National Institute for Health and Care Research.